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BAY1128688

Phase 1

Endometriosis | Small molecule | Endocrine |Bayer AG|Last Updated: May 19, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment51

FDA Designations

No designations recorded

Clinical trial landscape

BAY1128688 · 1 trial · 1 indication

Phase 1 1
NCT02434640Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1128688 After Multiple Oral Administrations in Healthy WomenEndometriosis
COMPLETED51 Analytics
PHASE1COMPLETED
Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1128688 After Multiple Oral Administrations in Healthy Women
EndometriosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Frequency of Treatment Emergent Adverse Events (TEAEs) with severity grading
Up to 2 months
Cmax,md (maximum concentration) of BAY1128688 after multiple dose
0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only)
Cav,md (average steady state concentration) of BAY1128688 after multiple dose
0, 15, 30, 60, 90min, 2, 3, 4, 6, 8, 12, 24h (24h: QD only)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
BAY1128688 [Dose1]EXPERIMENTALBAY1128688 dose level 1
BAY1128688 [Dose2]EXPERIMENTALBAY1128688 dose level 2
BAY1128688 [Dose3]EXPERIMENTALBAY1128688 dose level 3
BAY1128688 [Dose4]EXPERIMENTALBAY1128688 dose level 4
PlaceboPLACEBO_COMPARATORPlacebo to match arm 1,2, 3 and 4

Interventions

NameTypeDescription
BAY1128688DRUGPart A: Single dose and multiple dose for 14 days (postmenopausal women)
PlaceboDRUGPart A: Single dose and multiple dose for 14 days (postmenopausal women)
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Eligibility Criteria

Age Range18 Years to 68 Years
SexFEMALE
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: PART A * Postmenopausal state, revealed by 1. Medical history. One of the following: * Natural menopause at least 12 months prior to first study drug administration, * Surgical menopause by bilateral ovariectomy at least 3 months prior to first study drug administ...

Countries:Germany
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Frequently asked questions about BAY1128688

What is BAY1128688 used for?

BAY1128688 is an investigational small molecule being developed for endometriosis. It is an endocrine therapy candidate that has been studied in a Phase 1 clinical trial. The drug is not approved and remains in clinical development.

Who makes BAY1128688?

BAY1128688 is being developed by Bayer AG, a German pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker BAYRY. The drug is an investigational small molecule for the treatment of endometriosis.

What phase is BAY1128688 in?

BAY1128688 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug is not yet approved. It is being studied as a potential treatment for endometriosis, but further clinical development is required.

What clinical trials is BAY1128688 in?

BAY1128688 has one completed clinical trial, NCT02434640, an ascending dose study to investigate the safety, tolerability, and pharmacokinetics of BAY1128688 after multiple oral administrations in healthy women. The trial enrolled 51 participants in Germany and was placebo-controlled and double-blind.

Is BAY1128688 FDA approved?

BAY1128688 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial. The drug is being studied for endometriosis, but it has not received regulatory approval and remains in clinical development.